Evaluation of a Boosting Regimen With Oral Cholera Vaccine

This study has been completed.
Sponsor:
Collaborators:
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Information provided by (Responsible Party):
Sachin Desai, International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT01579448
First received: April 11, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.


Condition Intervention Phase
Cholera
Biological: Shanchol™, oral cholera vaccine
Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine
Other: no intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Open Labeled Controlled Trial to Evaluate the Immune Response of a Boosting Regimen With Shanchol™, a Killed Whole Cell Oral Cholera Vaccine (WC-OCV), in Previously Immunized Adults and Children in Eastern Kolkata, India

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Immunogenicity provided by a two dose boosting regimen of Shanchol™ [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To determine whether two doses of Shanchol™ administered to a previously immunized cohort elicits similar immune responses (greater than fourfold rise in serum vibriocidal antibody titers through IgM) to those achieved by a primary immunization series in an unimmunized cohort stratified by age (6-14 and ≥15 years old),


Secondary Outcome Measures:
  • Immunogenicity provided by a one dose boosting regimen of Shanchol™ [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To determine if a one dose booster regimen of Shanchol™ administered to a previously immunized cohort can elicit similar immune responses (through serum IgM) to those achieved by primary immunization in an unimmunized cohort stratified by age (6-14 and ≥15 years old)

  • Rises in serum IgA and IgG following boosting regimens [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Measure rises in serum IgA and IgG as an adjunct measure of immunogenic response to the Shanchol™ boosting regimens

  • Proportion of subjects with adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    To confirm the safety of one and two dose boosting regimens Shanchol™ in healthy, non-pregnant subjects stratified by age within 28 days following dosing in each intervention group. Screening for number of adverse events (AEs)and severe adverse events (SAEs) will done on all study visits. Adverse events screened for include: diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, and dryness of mouth. SAEs are those which are incapacitating, preventing normal activities, including death and hospitalization.


Enrollment: 426
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine to past vaccinated participants
The first arm includes subjects, who were immunized with two Shanchol™ doses, five years prior. In this study, arm one will receive one Shanchol™ booster dose at baseline and one booster dose on day fourteen.
Biological: Shanchol™, oral cholera vaccine

This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.

Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.

Active Comparator: Vaccine to past placebo recipients
The second arm includes subjects, who received two placebo doses, five years prior. Arm two will receive a primary immunization series consisting of one Shanchol™ dose at baseline and one at day fourteen
Biological: Shanchol™, killed, whole cell, bivalent, oral cholera vaccine

This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.

Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension.

Placebo Comparator: No intervention to past placebo recipients
The third arm includes subjects, who received two placebo doses, five years prior. This third arm will not receive any intervention and will serve to represent a baseline immune response by vaccine naïve individuals exposed to natural exposure.
Other: no intervention
No intervention will be given to this arm of past placebo recipients. To ensure that boosting was not due to natural exposure to Vibrio cholera, we will compare subjects in the boosting arm to this no intervention arm.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All subjects must be presently enrolled in the Phase 3 NICED RCT of Shanchol™ and satisfy the following criteria at study entry:

  1. Male or female adults aged 6 years and above, who are available for follow-up visits and specimen collection.

    • The subject should be able to continue in the study for the next 6 weeks
    • The subject (or parent/guardian) should be willing to provide 3 blood samples
  2. Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
  3. Healthy subjects as determined by:

    • Medical history
    • Physical examination
    • Clinical judgment of the investigator

Exclusion Criteria:

  1. individuals who are too weak to get out of bed to receive the vaccine
  2. pregnant women (identified through verbal screening)
  3. those less than 6 years of age
  4. Receipt of cholera vaccine following 2009 (time of licensure and availability of Shanchol™ in India)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579448

Locations
India
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India
Sponsors and Collaborators
Sachin Desai
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Investigators
Principal Investigator: Suman Kanungo, MBBS National Institute of Cholera and Enteric Diseases, India
  More Information

No publications provided

Responsible Party: Sachin Desai, ASSOCIATE RESEARCH SCIENTIST, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT01579448     History of Changes
Other Study ID Numbers: CR-WC-11
Study First Received: April 11, 2012
Last Updated: September 24, 2013
Health Authority: KOREA: INTERNATIONAL VACCINE INSTITUTE IRB
INDIA: NATIONAL INSTITUTE OF CHOLERA AND ENTERIC DISEASES
India: Indian Council of Medical Research
INDIA: SHANTHA BIOTECHNICS LTD

Keywords provided by International Vaccine Institute:
killed oral cholera vaccine
boosting vaccine regimen
safety and immunogenicity

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 20, 2014